scholarly journals Pattern of adverse drug reaction to antiepileptic drugs in a tertiary care hospital

2017 ◽  
Vol 6 (9) ◽  
pp. 2219
Author(s):  
Suchitra D. Akalu ◽  
Niveditha G. Belavadi
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Antiepileptic Drugs ◽  
Vascular System ◽  
Tertiary Care ◽  
Stevens Johnson Syndrome ◽  
Care Hospital ◽  
Entire Study ◽  
Monitoring Centre ◽  
Post Marketing Surveillance

Background: Adverse drug reactions (ADRs) are a major cause of morbidity and mortality, and are the leading cause of hospital admission. The overall rate of ADRs is estimated to be 6.5% and 28% of these ADRs are preventable. Antiepileptic drugs (AEDs) are authorized for several therapeutic indications and are highly prescribed. ADRs due to AEDs range from minor maculopapular exanthem (MPE) to severe life-threatening reactions like Drug reaction eosinophilia and systemic symptoms (DRESS) and Stevens-Johnson syndrome (SJS). Objective of the study was to evaluate the pattern of ADRs reported with AEDs in an adverse drug reaction monitoring centre (AMC) of a tertiary care hospital.Methods: Retrospective analysis of the records was done for a period 48 months from January 2013 to December 2016. During this period, all the ADRs caused by AEDs reported to the AMC were included in the study. The study evaluated the pattern of ADRs due to AEDs. The study also assessed the gender-wise distribution, predilection for various systems, causality, severity, and preventability of ADRs. Data was analysed using descriptive statistics.Results: A total of 319 ADRs were reported by spontaneous reporting during the entire study period. Out of the total 319 ADR reports received, antiepileptic drugs related ADRs were 35 (11%). Antiepileptic drugs which caused the ADRs included phenytoin, carbamazepine, clobazam and lorazepam. The most common system affected was dermatological (60%), followed by gastrointestinal system (17.14%), vascular system (11.42%), blood (5.8%), respiratory system (5.8%) and central nervous system (2.9%). Among the dermatological ADRs, SJS accounted for 11 cases of which 10 cases were due to phenytoin and one case was due to carbamazepine. DRESS syndrome due to phenytoin was documented in one case.Conclusions: AEDs are the most commonly prescribed drugs for various indications. Uses of AEDs are accompanied by ADRs which vary from mild rashes and itching to SJS and DRESS/TEN. Post-marketing surveillance of the AEDs is important for compliance, therapeutic efficacy and ultimately safety of the patient.

scholarly journals ANALYSIS OF ADVERSE DRUG REACTION IN A TERTIARY CARE HOSPITAL: A RETROSPECTIVE STUDY

2016 ◽  
Vol 10 (1) ◽  
pp. 347
Author(s):  
Dolly Roy ◽  
Ayan Purkayastha ◽  
Rohit Tigga
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Anaphylactic Reaction ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Iron Sucrose ◽  
World Health ◽  
Care Hospital ◽  
Monitoring Centre ◽  
Health Organization

ABSTRACTObjectives: Adverse drug reaction (ADR) is an important cause of morbidity, mortality, and prolonged hospitalization. The objective of this study is tomeasure the incidence, types, and nature of ADR in a tertiary care hospital located in Silchar, Assam.Methods: A retrospective noninterventional analysis of all ADRs reported by ADR Monitoring Centre, Department of Pharmacology, Silchar MedicalCollege, from March 2014 to February 2015 was performed. A total of 162 predesigned forms were used for collection of data. All forms were dulychecked for completeness, if not, they were rejected.Results: A total of 162 forms were assessed of which 96 (59%) were females and 66 (41%) were males. The distribution of ADRs in different age groupswere found to be 3 (1.85%) in 0-15 years, 71 (43.82%) in 16-30 years, 65 (40.12%) in 31-45 years, 8 (4.93%) in 46-60 years, and 15 (9.25%) in agegroup >60 years. 150 (92.6%) of the ADRs were serious and 12 (7.4%) were not serious. As per the World Health Organization causality assessmentscale, 120 (74.07%) were probable and 42 (25.92%) were possible. The most common ADR was anaphylactic reaction (AR) in 69 (42.59%) patients.The drugs which commonly caused ADR were iron sucrose infusions, nevirapine, cephalosporins, antiprotozoals, nonsteroidal anti-inflammatorydrugs, and quinolones followed by others.Conclusion: The majority of ADRs were probable. The most common ADR was AR caused by iron sucrose infusion. Different drugs caused differentADRs. ADRs thereby increase morbidity and mortality in patients as well as socioeconomic burden.Keywords: Adverse drug reaction, Anaphylactic reaction, Iron sucrose infusion, Noninterventional, Retrospective analysis.

scholarly journals ANTIMICROBIAL-RELATED ADVERSE DRUG REACTION IN A TERTIARY CARE HOSPITAL

2017 ◽  
Vol 10 (8) ◽  
pp. 229
Author(s):  
Jindal M ◽  
Sharma Rk
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Spontaneous Reporting ◽  
Tertiary Care Hospital ◽  
Past History ◽  
Tertiary Care ◽  
Care Hospital ◽  
Beta Lactam ◽  
Active Monitoring ◽  
Beta Lactam Antibiotics

  Objective: The objective of the study was to evaluate the adverse drug reaction (ADR) related to commonly used antimicrobials in a tertiary care hospital.Methods: A prospective spontaneous reporting study involving, active methods (pharmacist actively looking for suspected ADRs) and passive methods (stimulating prescribers to report suspected ADRs) was carried out in all departments of a tertiary care hospital, for 1 year. Patients of all age groups were included in the study. The data for the study were taken from case sheets, investigation reports of patients who had experienced an ADR, personal interviews with reporting persons or clinicians, personal interviews with patient or patient’s attendant, past history of medication use, which were generally obtained from, prescriptions from the past, reports of medical and surgical interventions, referral letters, ADR reporting forms. Collected data were then analyze for causality assessment by Naranjo’s scale and severity assessment by Hartwig and Siegel’s scale.Result: During 1 year of study period, 75 ADRs related to antimicrobial were reported among 1354 patients who were given antibiotic for the treatment. The incidence rate of antibiotic was found to be 5.53%. The department that reported ADR was medicine (10.16%), ENT (4.6%), pediatric (8.12%), orthopedics (06.9%), surgery (06.9%), chest and tuberculosis (04.6%), obstetrics and gynecology (06.9%), dentistry (02.3%), and skin (10.16%). The most common ADRs were related to gastrointestinal tract; dermatological reactions were second in the list of antimicrobial drugs causing ADR. In this study, among antimicrobials, fluoroquinolones, and beta-lactam antibiotics were the most common drugs causing gastrointestinal and dermatological ADRs. There was no unknown ADR reported that may need to be further investigated through active monitoring. All patients recovered from ADRs without any complications. The causality was assessed by Naranjo’s scale and it revealed that out of 75 antibiotics related ADR 48 (64%) were possible, 27 (36%) were probable, 3 (4.00%) were definate, and 0% were unlikely. According to the Hartwig and Siegel’s scale, most of ADR were mild 45 (60%) and moderate 30 (40%) in nature.Conclusion: ADRs related to antimicrobials occurs frequently. Among antimicrobials, fluoroquinolones, and beta-lactam antibiotics were the most common drugs causing gastrointestinal and dermatological ADRs. The health-care system can promote the spontaneous reporting of antimicrobial ADR to pharmacovigilance center for ensuring safe drug use and patient care.

scholarly journals Knowledge, attitude and practice toward adverse drug reaction reporting among practicing clinicians at a tertiary care hospital

2017 ◽  
Vol 6 (4) ◽  
pp. 845
Author(s):  
Toshan L. Todar ◽  
Manju Agrawal ◽  
Rajesh Hishikar ◽  
Anuja Jha ◽  
Basant Maheshwari ◽  
...  
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Tertiary Care ◽  
Reaction Monitoring ◽  
Adverse Drug Reaction Monitoring ◽  
Medical College ◽  
Monitoring Centre ◽  
Adr Reporting ◽  
Attitude And Practice ◽  
Knowledge Attitude And Practice

Background: Pharmacovigilance has evolved as an important tool for dealing with Adverse Drug Reactions (ADRs) both in pre-marketing and post-marketing scenario. Underreporting of ADRs at our Adverse drug reaction Monitoring Centre (AMC) led us to conduct this study to assess Knowledge, Attitude and Practice (KAP) of the practicing clinicians at our tertiary care Pt. J.N.M. Medical College associated Dr. B.R.A.M. Hospital, Raipur, Chhattisgarh, India, towards ADRs reporting.Methods: This was a cross-sectional study using pretested questionnaires consisting of 29 questions related to KAP of the practicing clinicians at Pt. J.N.M. Medical College associated Dr. B.R.A.M.  Hospital, Raipur towards ADRs reporting. The percentage of responders for each question was calculated. All statistical analysis was performed in Microsoft Office Excel 2007.Results: Out of 135 questionnaires distributed only 100 were considered for analysis, so the overall response rate was 74.07%. We calculated the result from the 100 responders. Overall 77% responders were aware of existence of ADR monitoring system in India, while only 40% were aware of its existence at their hospital. Only 8% responders had reported ADRs to the National Pharmacovigilance Centre and 10% to the Adverse drug reaction Monitoring Centre (AMC) at their hospital. Lack of knowledge about where, how and whom to report ADRs, lack of time, inability to decide what to report (known or unknown ADRs) and unavailability of ADR reporting form were the important factors discouraging them reporting ADRs.Conclusions: Creating awareness regarding ADR reporting through CMEs among practicing clinicians and early sensitization at medical undergraduate level for medical students may improve the current ADR reporting rate.  

scholarly journals IMPACT OF CERTAIN EDUCATIONAL INTERVENTIONS ON ADVERSE DRUG REACTION REPORTING BY NURSING HEALTH PROFESSIONALS AT A TERTIARY CARE HOSPITAL

2020 ◽  
pp. 175-180
Author(s):  
SUPRIYA SONOWAL ◽  
CHETNA K DESAI ◽  
JIGAR R PANCHAL
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Health Professionals ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Educational Interventions ◽  
Care Hospital ◽  
Post Intervention ◽  
Adr Reporting ◽  
Nursing Health

Objectives: The objectives of the study were to evaluate the impact of certain educational interventions on adverse drug reaction (ADR) reporting by nursing health professionals at a tertiary care hospital. Methods: Knowledge, attitude, and practice (KAP) of the nurses regarding ADR reporting were evaluated before and after interventions using a KAP questionnaire. Educational interventions carried out among the nurses were workshops, booklets, SMSes, personal briefings, and posters. Number and quality of ADR reported by nurses in pre-intervention (3 months), intervention (10 months), and post-intervention (3 months) phase were compared. Results: There was a significant increase in response rate to questionnaires in the post-intervention phase (post-IP) (97.74%) as compared to pre-intervention (91.28%) phase (pre-IP). The knowledge score of the nurses increased significantly in post-IP (11.65 ± 2.14) as compared to the pre-intervention (6.98 ± 2.46) phase. No ADR was reported by nurses in pre-IP. Thirty nurses reported 30 ADRs in the intervention phase and six nurses reported six ADRs in the post-IP. The mean score of completeness of ADR notification forms decreased significantly in post-IP. Maximum ADRs (10) were reported after the workshops. Conclusion: Educational interventions improved the KAP of ADR reporting by nurses, albeit temporary. This suggests the need of continuous educational interventions.

scholarly journals Adverse Drug Reaction Policy in a Tertiary Care Hospital

2015 ◽  
Vol 3 (1) ◽  
pp. 41-47
Author(s):  
V Aggarwal ◽  
Shakti Kumar Gupta ◽  
DK Sharma ◽  
S Arya ◽  
S Singh
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Healthcare Providers ◽  
Cross Sectional Study ◽  
Care Hospital ◽  
Cross Sectional ◽  
Study Population ◽  
Personnel Paramédical

ABSTRACT Adverse drug reactions (ADRs) are a significant cause of morbidity and mortality and contribute to the incidence of adverse events, resulting in increased healthcare costs. Healthcare providers need to understand their role and responsibility in the detection, management, documentation, and reporting of ADRs. The purpose of this study is to provide guidelines regarding the procedure of reporting ADRs to hospital authority. It was a descriptive cross-sectional study carried out between April and August 2013. The study population included doctors, nursing personnel, paramedical staff and quality managers of tertiary care hospital from one public and two private hospitals. Interaction was done with study population against the back drop of the checklist and ADR policy was formulated. How to cite this article Singh S, Gupta SK, Arya S, Sharma DK, Aggarwal V. Adverse Drug Reaction Policy in a Tertiary Care Hospital. Int J Res Foundation Hosp Healthc Adm 2015; 3(1):41-47.

scholarly journals A Retrospective Descriptive Study of Adverse Drug Reaction Monitoring in Tertiary Care Hospital

2020 ◽  
Vol 3 (2) ◽  
pp. 54-58
Author(s):  
Ajay K Gupta
Keyword(s):  
Adverse Drug Reaction ◽  
Drug Reaction ◽  
Tertiary Care Hospital ◽  
Tertiary Care ◽  
Descriptive Study ◽  
System Organ Class ◽  
Therapeutic Effects ◽  
Care Hospital ◽  
Reaction Monitoring ◽  
Adverse Drug Reaction Monitoring

ABSTRACT Introduction An adverse drug reaction (ADR) is any undesirable effect of a drug to the patient beyond its anticipated therapeutic effects while used clinically. Aims and objective To analyze the incidence of ADRs in a tertiary care hospital reported from April 2015 till December 2017. Materials and methods Two hundred ADR forms were included in the study and analyzed. These were codified into various drug classes according to anatomical therapeutic chemical (ATC) classification based on WHO–ATC Index 2019 besides categorized into preventable or not modified Schumock and Thornton scale. Severity was assessed based on a scale by Hartwig et al. Also, the ADRs were classified based on MedDRA 13.01 to system organ class (SOC) and preferred terms (PT) falling under respective SOC. Results Maximum ADRs were reported by dermatology. Most commonly, it involved gastrointestinal system (GIT) followed by skin. Antibiotics and anti-cancer drugs caused maximum ADRs. About two-thirds were classifiable as moderate to severe, whereas about one-third were preventable. About 10% of cases were such that left deep impact of sequelae or were not recovered and one case was fatal. Conclusion Extreme vigilance by clinicians is of utmost crucial virtue in detecting, diagnosing, and reporting such ADR for continued drug safety monitoring. How to cite this article Gupta AK. A Retrospective Descriptive Study of Adverse Drug Reaction Monitoring in Tertiary Care Hospital. J Med Acad 2020;3(2):54–58.

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